A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
CEDOES
Vitória, Espírito Santo, Brazil
Sociedade Beneficente São Camilo
Campinas, São Paulo, Brazil
Instituto De Pesquisa Clínica De Campinas IPECC
Campinas, São Paulo, Brazil
Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA
São Paulo, São Paulo, Brazil
efficacy
The efficacy analysis will be at the per protocol population, with the VAS measure after three treatment dosages. The VAS scale consists on a straight line of 100 mm in which the patient marks, at any point through the straight line, the point he/she considers to describe the pain level he/she feels. After the patient marks the straight line, classifying his/her pain, it is measured with a millimeter-graded standard rule, the distance between the mark and the extremity "No pain" at the scale.
Time frame: 6 months
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Hospital Santa Marcelina
São Paulo, São Paulo, Brazil
Faculdade de Medicina ABC
São Paulo, São Paulo, Brazil